NEW DELHI--In 2005, with barely US$300 in her bank account, Nidhi Saxena took the bold step forward to pursue her dream of becoming an entrepreneur and founded Karmic Lifesciences.

Nidhi Saxena

Today, the Mumbai-headquartered clinical research organization (CRO) clocks revenue of about US$10 million and is targeting to increase this number to US$19.3 million by 2014. The company provides a range of services from new drug development to concept clinic services, and counts leading global pharmaceutical and biotech companies among its key customers.

It leverages cloud computing and its own IT capabilities to offer cost-efficient products including its Web-based clinical platforms kClinion, kTrials and kMetrics.

Saxena, 38, who is also company president and CEO, saw the opportunity in the CRO market which was lacking in innovation and identified three key focus areas: data entry, data compliance, and drug compliance.

In an interview with ZDNet Asia, she discusses new projects Karmic is working on and India's potential to be a leading CRO destination.

Q: You've worked with companies like GE Capital, WNS North America, Wipro and Hexaware. How did you come up with the idea of Karmic?I worked for three to four years before enrolling for an MBA in 2000. Since the beginning, I was sure about becoming an entrepreneur. By the time I completed my Masters in 2002, the IT and BPO (business process outsourcing) space was saturated. The life sciences industry excited me. There was a lot of thrust on research and innovation. The data management part in a CRO is very similar to that of a BPO or a KPO (knowledge process outsourcing).

CROs offered a lot of opportunity for innovation.

How did you go about it?When I set out to incorporate Karmic, I had only 15,000 rupees (US$289.6) in my bank account. I incorporated the company in 2005 and gave it to someone else to run it. Meanwhile, I went off to New York to work for WNS.

In the U.S., I met a New Jersey-based angel investor. We raised 10 million rupees (US$193,067) through the Indian Angel Network and at the same time, Novartis gave us a 10 million-rupee contract for data management. I quit WNS in June 2008 and returned to India.

Even though it was incorporated in 2005, Karmic has been operational only for the last three and a half years. We started by focusing on sales. Since I wasn't from the industry, I worked on creating a strong network of doctors and pharmacists, and met several people from the pharmaceutical and healthcare sectors. There was a lot of learning to do.

Today, we have a dedicated team of 81 people working for us that includes several doctors, PhDs, science graduates and pharmacists.

How did you carve a niche for Karmic in the CRO space?We first went about studying the industry and products available in the market to understand whether they really meet the needs of the pharmaceutical industry. We also looked at the kind of innovation that was happening. We realized that none of the big players were offering anything unique. There was a lot of scope for innovation.

Using science and IT as our main planks, we innovated products like kClinion which is a highly-scalable, Web-based, electronic data capture (EDC) platform designed to support global, multi-centric Phase II to IV clinical trials.

In India, data is still captured largely on paper for clinical studies. When pharma companies run clinical studies at sites such as hospitals, the doctor or principle investigator treats the patient in line with the protocol. Most doctors in India also capture information in paper. It takes months to type that information, correct it, raise queries against it, and collate that data against 30 to 40 countries where the clinical study maybe going on. Through kClinion, the doctor fills up a very simple form at the site and enters all the data.

kMetrics is an integrated Web-based, metrics-reporting dashboard that collates data from multiple systems across a single program on a daily or weekly basis, and provides a customized, real-time view of all key study-related project metrics to the sponsor.

Are you working on new projects?We are working on three things. First, we are looking to make data entry easier for the principle investigator. We want to make kClinion available on iPads and iPhones so that a busy doctor can type or handwrite the data to be fed for a clinical study on the device.

Second, in India, data compliance is a huge issue. In order to ensure the data belongs to a particular patient, we are introducing a retinal scan in the system. No other company in the world is doing this.

Third, the issue of drug compliance. People forget to take medicines and then complain the medicine is no good. We have introduced a nano-card that ensures drug compliance. Every patient who is part of the clinical study gets a box. The patient has to swipe the card each time he takes a pill or an injection. The nano card uses a GSM chip, which gives us real-time information about how many times the patient has not opened the box, and therefore, not taken the medicine. We use cloud to deliver this application.

We are also working on a data repository that collates all the data and does a meta-analysis across multiple clinical trials.

How do you achieve cost-efficiencies?We leverage the cloud. I have an IT background so I idealize these solutions and develop the specifications. Relevance Labs in Bengaluru programs it for us. The company supports our entire IT requirement, although Karmic owns the intellectual property for all these solutions.

In clinical research, what are some of the important areas for you?We are quite focused on oncology. It is one of the biggest segments for us and is growing at nearly 12 to 13 percent per annum, as opposed to the pharma industry which is growing at 6 to 7 percent per annum.

India has nearly 700,000 cancer patients. The treatment is not only expensive, but also requires high-end skills. We are now working on predictive technologies like cancer biomarkers so that pharma companies can get better results for their clinical studies.

Can you discuss Karmic's revenues and how the company is to grow in the future?Our business contracts are upward of US$10 million and our revenues are expected to be in the same range. The growth this year has been over 400 percent. We are targeting a turnover of 1 billion rupees (US$19.3 million) by 2014.

With high growth, is retaining talent a challenge for you? How do you keep your team motivated?From employees to suppliers, our culture is very entrepreneurial. At Karmic, attrition is less than 15 percent, compared to other CROs where it is as high as 70 percent. In the case of BPOs, it is 100 percent.

We are also focusing on training. We have a learning management system called KarmaGyan on our Web site. We put all training packages in a bucket and people are encouraged to take on these packages.

How do you see growth in India's CRO industry?The CRO industry should hit US$5 billion in the next two to three years, from US$1 billion today. CROs are a huge employment opportunity for India, which is being touted as the number one CRO destination due to several factors.

First, we have a huge population base of 1.2 billion, including 80 million diabetics. Second, we have 7 to 8 different genetic patterns. Third, we have a pool of highly talented doctors. Fourth, we have a rich pool of talent in the field of IT. Fifth, every year we produce 700,000 science and engineering graduates that can be trained for the CRO industry in a very short time.

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